Franken jumps into medtech fray

WASHINGTON – DFL Sen. Al Franken is the latest in a series of Minnesota lawmakers drafting bills to speed up the approval of medical devices.

Franken’s bill, released Tuesday and co-sponsored with fellow Senators Lamar Alexander (R-TN) and John Kerry (D-MA), eases some conflict of interest rules affecting outside experts on Food and Drug Administration review panels and lifts an FDA rule that caps profits for devices that treat rare conditions. Easing that rule is intended to encourage companies to develop devices that would otherwise serve a very small number of patients.

“My legislation would remove unnecessary barriers so that these critical medical devices get to the patients that need them as quickly and safely as possible,” said Franken in a written statement.

His legislation follows bills released by DFL Sen. Amy Klobuchar and GOP Rep. Erik Paulsen that are also intended to speed up the time it takes the FDA to review medical devices. All three bills ease the conflict of interest rules for outside experts, albeit in different ways. Franken’s is the only bill to address the issue of treating rare conditions.

Minnesota’s medical device industry includes large firms such as Medtronic and St. Jude Medical, as well as smaller venture-capital funded firms. The industry has ramped up its congressional lobbying efforts recently, arguing that a slowing FDA approval process is putting American companies at a competitive disadvantage vis a vis overseas rivals.

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